Regulatory Operations could be described as the ‘quiet but rather important engine behind the scenes, keeping operations running smoothly to meet the many diverse needs of the industry’ – therefore Regulatory Operations Optimization and Transformation is at the forefront of change and taking advantage of enhanced and exciting digital possibilities (within Europe and globally). Therefore, key topics of emerging and ongoing interest include: personalized healthcare and how the patient being at the center of their healthcare journey is key, digital transformation, including cloud submissions and automation like RPA and web-scraping, as well as how the future of regulatory operations landscape will evolve and change the skillsets of this organization.

Who is This Track Designed For?

This track is ideal for professionals leading and working in regulatory operations and for those on the agency side assessing and approving dossiers. It may be also of interest to patients and patient advocacy organisations. Professionals involved in regulatory operations, regulatory submissions, eCTD, document management and regulatory solution providers.

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